SuspendedPhase 1

Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer

Stopped: Drugs unavailable

United States12 participantsStarted 2022-09-09

Plain-language summary

One of the ways that cancer grows and spreads is by avoiding the immune system.NK cells are immune cells that kill cancer cells, but are often malfunctioning in people with colorectal cancer and blood cancers. A safe way to give people with colorectal cancer and blood cancers fresh NK cells from a healthy donor has recently been discovered. The purpose of this study is to show that using two medicines (vactosertib and IL-2) with NK cells will be safe and will activate the donor NK cells. NK cells and vactosertib are experimental because they are not approved by the Food and Drug Administration (FDA). IL-2 (Proleukin®) has been approved by the FDA for treating other cancers, but the doses used in this study are lower than the approved doses and it is not approved to treat colorectal cancer or blood cancers.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must have one of the following: * Histologically confirmed locally advanced or metastatic colon or rectal adenocarcinoma * Histologically confirmed locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma * Relapsed or refractory hematologic malignancy * Acute myeloid leukemia with measurable residual disease (MRD) relapse * MRD relapse is defined as presence of ≥ 1 in 10-4 nucleated cells per European LeukemiaNet 2021 guidance \[49\]: (1) conversion of MRD negativity to MRD positivity, independent of the MRD technique, or (2) increase of MRD ≥1 log10 between any two positive samples measured in the same tissue (PB or BM) in patients with MRD-Low Level * Patients will be eligible if they have declined or are ineligible for standard treatment options and if there is no standard approach to curative therapy per NCCN guidelines. Patients with solid tumors must have had progression on at least one standard line of therapy. * Hematologic malignancies in the relapsed or refractory setting can include: * Acute myeloid leukemia * Myelodysplastic syndrome * Acute lymphoblastic leukemia * Chronic myeloid leukemia * Chronic lymphocytic leukemia * Non Hodgkin Lymphoma * Hodgkin Lymphoma * Myeloproliferative syndromes * Plasma cell myeloma * Subjects must have recovered from acute toxicities of prior chemotherapy or stem cell transplant. Any prior non-hematologic vita…

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

Timeframe: Within 28 days of NK cell infusion

Persistence of donor NK cells

Timeframe: 7 days post-treatment

Trial details

NCT IDNCT05400122

SponsorDavid Wald

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31